Agriculture
November 9, 2023
Product Description
The Odon Device was designed for assistive birth delivery in cases of prolonged labor, transverse, or breech babies. The device, which is currently under clinical trial, is intended to reduce complications from prolonged labor, such as infection, and newborn complications, such as birth asphyxia.
Target Regions
Africa, Central Asia, East Asia, East Asia and Pacific, North Asia, South America, South Asia, Southeast Asia
Target SDGs
SDG 3: Good Health and Well-Being
Market Suggested Retail Price
$50.00
Target Users (Target Impact Group)
Community, Small and Medium-sized Enterprises
Distributors / Implementing Organizations
WHO, Becton Dickinson and Company
Manufacturing/Building Method
The Becton Dickinson Company has the rights to manufacture the Odon Device, however, manufacturing has not yet begun.
Intellectural Property Type
Patent Protected
User Provision Model
Product is not yet available on the market
Distributions to Date Status
None
Design Specifications
The Odon Device is a vaginal delivery device that employs a circumferential air cuff over the fetal head to perform instrumental vaginal delivery. The product consists of a soft plastic cup that fits around the head of the baby, an inserter that grasps the head, and a polyethylene sleeve that is inflated with air that allows for the guidance of the baby out of the birth canal. A force of up to 19 kg can be applied to aid in the extraction process.
Product Schematics
Technical Support
None
Replacement Components
Unknown
Lifecycle
Unknown
Manufacturer Specified Performance Parameters
Performance targets include: low cost, compact dimensions, usable globally, ease of use, safe for both fetus and mother, reduces risk of inoculability between mother and child.
Vetted Performance Status
The WHO Human Reproduction Program supported the evaluation of this product in hospitals in Argentina and South Africa. The device was successfully inserted into 93% of women, and 71% had a successful delivery after one-time application.
Safety
There are risks of mechanical failure while operating, and of maternal or newborn trauma during use.
Complementary Technical Systems
None
Academic Research and References
Requejo, J.H. and Belizán, J.M., 2013, Odon Device: a Promising Tool to Facilitate Vaginal Delivery and Increase Access to Emergency Care, Reproductive Health, 10(1), pp. 42.
World Health Organization Odon Device Research Group, 2013, Feasibility and Safety Study of a New Device (Odón Device) for Assisted Vaginal Deliveries: Study Protocol, Reproductive health, 10(1), pp. 33.
Schvartzman, J., Krupitski, H., Merialdi, M., Betran, A.P. and Requejo, J., 2018, Odon Device for Instrumental Vaginal Deliveries: Results of a Medical Device Pilot Clinical Study, Reproductive health, 15(1), pp. 45.
O’brien, S., Winter, C., Burden, C., Boulvain, M., Draycott, T., and Crofts, J., 2017, Fetal Head Position and Perineal Distension Associated with the Use of the BD Odon Device™ in Operative Vaginal Birth: a Simulation Study, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 10–18.
O’brien, S., Mouser, A., Odon, J., Winter, C., Draycott, T., Sumitro, T., Alisantoso, D., Lim, W., Merialdi, M., Stankovic, A., et al, 2017, Design and Development of the BD Odon DeviceTM: a Human Factors Evaluation Process, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 35–43.
O’brien, S., Winter, C., Burden, C., Boulvain, M., Draycott, T., and Crofts, J., 2017, Pressure and Traction on a Model Fetal Head and Neck Associated with the use of Forceps, Kiwi™ Ventouse and the BD Odon Device™ in Operative Vaginal Birth: a Simulation Study, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 19–25.
Compliance with regulations
The device has not been approved for use in the US but has been evaluated by the WHO, which found that the device was feasible but will require a randomized-controlled trial to evaluate effectiveness and safety compared to other accepted methods.
Other Information
None
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